FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AVL #980 ELECTROLYTE ANALYZER
K Number: K801011
·
Decision Jul 8, 1980
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
161
Applicant Total
2
Review Days
74
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Basic Information
- Device Name
- AVL #980 ELECTROLYTE ANALYZER
- K Number
- K801011
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1665
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Gauntlet Technology Corp.
- Date Received
- April 25, 1980
- Decision Date
- July 8, 1980
- Product Code
- JGS
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JGS | Electrode, Ion Specific, Sodium | FDA class 2 | Clinical Chemistry |
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Other Clearances by Gauntlet Technology Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K792230 | AVL MODEL 940 AUTOMATIC PH/BLOOD GAS | Dec 31, 1979 | Substantially Equivalent |